Greenlight Guru01.19.22
Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP), has acquired CanvasGT, a software company that creates a modern solution for medical device companies to collaborate on initial designs and concepts prior to establishing a quality system and implementing formal design controls. Their visual, user-friendly solution enhances the research and design phases for medical device innovators by providing a solution that enables a collaborative, creative, and iterative process while seamlessly capturing design history along the way.
The emphasis on medical device design controls is founded on research from the FDA that shows 44% of voluntary recalls associated with quality problems in the market could have been prevented by adequate design controls. For medical device innovators, there is little to no guidance on getting started and how to establish what is necessary for the regulators. Even common design frameworks have been misinterpreted or unsupported by technologies needed in the pre-design control phases that support product design as an evolutionary process. And waiting until design lock to implement design controls or reverse-engineering design history is costly, time-consuming, and turns what should be a quality activity into an administrative burden.
“The opportunity to help medical innovators in the early stages of design accelerate and improve their downstream success inspired us to start CanvasGT,” said Andrew DiMeo, founder & CEO at CanvasGT, “I’m especially proud of the acquisition by Greenlight Guru because our shared vision of medical device success protects that strategic focus. Working together ensures delivering the solution to the users so that more life-saving innovations can successfully get to market faster.”
“For years, customers have asked us for our expertise when they are early in the R&D process,” said David DeRam, CEO at Greenlight Guru, “With CanvasGT, not only can we assist them earlier with expertise, but now we’ll be able to help implement true quality into their devices from the very beginning of the ideation process allowing them to iterate faster, design better, safer devices and influence medical device innovators view of design controls from burdensome to a best practices that gives them an advantage.”
Stuart Lindquist, director, R&D for Emergency Medicine at Teleflex Medical, when speaking about the CanvasGT product said, “Finally, a tool that allows inventors and teams to collaboratively brainstorm ideas and solutions to unmet needs, while simultaneously creating design history file documentation along the way. This allows for a more creative and more efficient product development process.”
Anthony Voiers, CEO of Advanced Chemotherapy Technologies, added, “Typically companies end up reverse engineering design controls after the fact, which can take months of effort at the exact time you are planning your FDA submission. I’m very excited to see this pain point resolved.”
Greenlight Guru and CanvasGT’s combined capabilities will support early-stage medical device companies and those coming out of larger medical innovation programs by allowing them to improve product quality, increase creativity, get to market faster, and increase new product introduction success ultimately leading to safer and more effective medical devices.
The CanvasGT team will be joining Greenlight Guru and establishing a Greenlight Guru presence in Raleigh, North Carolina.
This acquisition follows the announcement of Guru Assist, a flexible way to leverage medical device expert assistance. This new service offering provides Greenlight Guru expert help exactly when and where customers need it with on-demand assistance accessed from where people are working—the Greenlight Guru platform.
The emphasis on medical device design controls is founded on research from the FDA that shows 44% of voluntary recalls associated with quality problems in the market could have been prevented by adequate design controls. For medical device innovators, there is little to no guidance on getting started and how to establish what is necessary for the regulators. Even common design frameworks have been misinterpreted or unsupported by technologies needed in the pre-design control phases that support product design as an evolutionary process. And waiting until design lock to implement design controls or reverse-engineering design history is costly, time-consuming, and turns what should be a quality activity into an administrative burden.
“The opportunity to help medical innovators in the early stages of design accelerate and improve their downstream success inspired us to start CanvasGT,” said Andrew DiMeo, founder & CEO at CanvasGT, “I’m especially proud of the acquisition by Greenlight Guru because our shared vision of medical device success protects that strategic focus. Working together ensures delivering the solution to the users so that more life-saving innovations can successfully get to market faster.”
“For years, customers have asked us for our expertise when they are early in the R&D process,” said David DeRam, CEO at Greenlight Guru, “With CanvasGT, not only can we assist them earlier with expertise, but now we’ll be able to help implement true quality into their devices from the very beginning of the ideation process allowing them to iterate faster, design better, safer devices and influence medical device innovators view of design controls from burdensome to a best practices that gives them an advantage.”
Stuart Lindquist, director, R&D for Emergency Medicine at Teleflex Medical, when speaking about the CanvasGT product said, “Finally, a tool that allows inventors and teams to collaboratively brainstorm ideas and solutions to unmet needs, while simultaneously creating design history file documentation along the way. This allows for a more creative and more efficient product development process.”
Anthony Voiers, CEO of Advanced Chemotherapy Technologies, added, “Typically companies end up reverse engineering design controls after the fact, which can take months of effort at the exact time you are planning your FDA submission. I’m very excited to see this pain point resolved.”
Greenlight Guru and CanvasGT’s combined capabilities will support early-stage medical device companies and those coming out of larger medical innovation programs by allowing them to improve product quality, increase creativity, get to market faster, and increase new product introduction success ultimately leading to safer and more effective medical devices.
The CanvasGT team will be joining Greenlight Guru and establishing a Greenlight Guru presence in Raleigh, North Carolina.
This acquisition follows the announcement of Guru Assist, a flexible way to leverage medical device expert assistance. This new service offering provides Greenlight Guru expert help exactly when and where customers need it with on-demand assistance accessed from where people are working—the Greenlight Guru platform.
